| Primary Device ID | 00850019947991 |
| NIH Device Record Key | 6144ec3e-ca2b-4c0a-9071-56800a35c548 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dermal Cooling System |
| Version Model Number | M1-TIP1-20 |
| Catalog Number | M1-TIP1-20 |
| Company DUNS | 080023734 |
| Company Name | R2 DERMATOLOGY INC. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com | |
| Phone | +1(925)378-4400 |
| info@r2technologies.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850019947564 [Primary] |
| GS1 | 00850019947861 [Primary] |
| GS1 | 00850019947991 [Unit of Use] |
| ILO | Pack, hot or cold, water circulating |
| QPZ | Contact cooling for skin lesion pain relief |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
| B563HP0030 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| B563HP0020 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| B563C20010 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| B563HP0050 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| B563HP0040 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| 00850019947182 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| 00850019947014 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| 00850019947007 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| 00850019947533 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| 00850019947045 | The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedur |
| 00850019947632 | Dermal Cooling System dermabrasion tip |
| 00850019947991 | Dermal Cooling System smooth tip |